An interventional study of Physical therapist support in Stroke, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Basic science
The purpose of this study is to systematically determine the effect of unnecessary physical therapist assistance in individuals after stroke during the practice of an upper limb task on an individual's task performance and their underlying motor control patterns when learning (or re-learning) motor skills.
Independent motor task performance is the most highly prioritized outcome of physical therapy for individuals with motor disability. Accordingly, a key priority for physical therapists in multiple practice settings is the advancement of functional motor independence. Therapists must determine when a patient requires assistance (e.g., verbal cues, physical support) to complete a motor task and when a patient is able to execute a motor skill with less assistance. If a therapist does not provide enough support, the patient is at risk for unsuccessful task performance. As such, therapists often default to providing a higher level of assistance.
An individual following stroke, for instance, may demonstrate an increased magnitude of postural sway while completing self-care activities at the sink. A therapist may decide to provide physical support for the patient to decrease sway variability, whether or not the patient requires this support to maintain performance. The motor control consequences of providing this assistance (thus constraining movement variability and providing fewer options for adapting movement) when assistance is actually not needed is unknown. The purpose of this study is to systematically determine the effect of unnecessary assistance during the practice of an upper limb task on functional performance and underlying motor control patterns when learning (or re-learning) motor skills in individuals with stroke. The insights gained from the current project will have the potential to improve the currently available physical therapy interventions for individuals with stroke.
The effects of unnecessary physical therapist support will be examined in terms of upper limb task performance, retention, and transfer, and in terms of the postural control supporting task performance. The study is currently planned for individuals with stroke. Participants will be required to maintain the position of a virtual laser within a target while standing. An experimental group will receive postural support (physical assistance to maintain upright posture) during a practice period in order to specifically determine the effect of postural support on upper limb task performance and postural sway patterns. Participants will also engage in a light finger force production transfer task to ascertain the influence of postural support on a different supra-postural task.
It is hypothesized that providing unnecessary assistance (and thus limiting independence) during practice of a novel motor task will result in (a) faster improvements in task performance but reduced retention and more limited transfer to another, similar task; and (b) reduced task- sensitive postural sway adjustments (measured in terms of both the quantity and temporal structure) during practice, at transfer, and at retention, reflecting reduced adaptability of postural patterns to task demands.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Behavioral: Physical therapist support
Participants will receive no physical therapist support while completing the task.
Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
Center of Pressure Path Length
The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb.
Time frame: 10 minutes of practice
Standard Deviation of Center of Pressure
Variability of center of pressure trajectory.
Time frame: After 10 minutes of practice
Percent Determinism of Postural Sway
Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway.
Time frame: After 10 minutes of practice
Entropy (Sample Entropy)
Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values.
Time frame: After 10 minutes of practice
Percent Correct
Percent time on target.
Time frame: After 10 minutes of practice
| Milestone | Experimental Group | Control Group |
|---|---|---|
| Started | 13 | 12 |
| Completed | 11 | 12 |
| Not completed | 2 | 0 |
| Withdrew: Unable to complete experimental task | 2 | 0 |
The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb.
| cm^2 | Experimental Group | Control Group |
|---|---|---|
| Center of Pressure Path Length | 98.5 ± 17.5 | 156.1 ± 16.8 |
Variability of center of pressure trajectory.
| cm | Experimental Group: Paretic Limb | Control Group: Paretic Limb | Experimental Group: Non-Paretic Limb | Control Group Non-Paretic Limb |
|---|---|---|---|---|
| Standard Deviation of Center of Pressure | .70 ± .06 | .53 ± .05 | .69 ± .04 | .53 ± .04 |
Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway.
| percent determinism | Experimental Group: Paretic Limb | Control Group: Paretic Limb | Experimental Group: Non-Paretic Limb | Control Group: Non-Paretic Limb |
|---|---|---|---|---|
| Percent Determinism of Postural Sway | .99 ± .001 | .99 ± .001 | .99 ± .001 | .99 ± .001 |
Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values.
| ratio of AP:ML | Experimental Group: Non-Paretic Limb | Control Group: Non-Paretic Limb | Experimental Group: Paretic Limb | Control Group: Paretic Limb |
|---|---|---|---|---|
| Entropy (Sample Entropy) | 1.2 ± .19 | 1.54 ± .18 | 1.4 ± .18 | 1.1 ± .19 |
Percent time on target.
| percentage of time on target | Experimental Group: Paretic Limb | Control Group: Paretic Limb | Experimental Group: Non-Paretic Limb | Control Group: Non-Paretic Limb |
|---|---|---|---|---|
| Percent Correct | .66 ± .08 | .74 ± .06 | .95 ± .01 | .91 ± .01 |
Collected over No adverse events occurred during the study (1 hour, single session). Participants were only assessed for adverse events during the 1-hour single session. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Group | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Control Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Experimental Group | Control Group |
|---|---|---|
| FallMusculoskeletal and connective tissue disorders | 0/11 | 0/12 |
| Age, Continuous(years) | Experimental Group | Control Group | Total |
|---|---|---|---|
| Mean | 57 ± 4.3 | 50.8 ± 8.4 | 53.7 ± 7.3 |
| Sex: Female, Male(Participants) | Experimental Group | Control Group | Total |
|---|---|---|---|
| Female | 7 | 10 | 17 |
| Male | 4 | 2 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 12 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 7 | 11 |
| White | 7 | 5 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Analytic code and other study materials may be shared on PI's Open Science Framework (OSF) page.
Supporting information: Analytic code
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Cincinnati